Article R1123-54
…arations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions occurring…
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Showing 1651–1660 of 36396 articles for “Art. Décret n° 2015-1437 du 5 novembre 2015”
…arations defined in Article L. 1243-1, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reactions occurring…
The sponsor shall inform the competent authority and the Committee for the Protection of Individuals without delay of the new facts defined in 12° of Article R. 1123-46 and, where appropriate, of the…
…nd in vitro diagnostic medical devices, the sponsor must report to the Agence nationale de sécurité du médicament et des produits de santé any suspected serious unexpected adverse reaction and any ser…
For the research referred to in 1° of Article L. 1121-1 involving labile blood products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de santé any adverse…
For the research mentioned in 1° of Article L. 1121-1 involving the products mentioned in I of Article R. 1211-29 with the exception of cell therapy preparations, the sponsor shall report to the Agenc…
For the research mentioned in 1° of Article L. 1121-1 concerning the products mentioned in I of Article R. 1211-29, with the exception of cell therapy preparations, the investigator who has knowledge…
For the research mentioned in 1° of Article L. 1121-1 other than that mentioned in Articles R. 1123-54 to R. 1123-58, the sponsor must report to the competent authority any suspected serious unexpecte…
For the research mentioned in 1° of Article L. 1121-1 concerning cosmetic products or tattooing products, the sponsor shall report to the Agence nationale de sécurité du médicament et des produits de…
…WORDING RESULTING FROM L. 1121-1 Order no. 2022-1086 of 29 July 2022 L. 1121-2 Law no. 2012-300 of 5 March 2012 L. 1121-3 Order no. 2016-800 of 16 June 2016 L. 1121-4 Order no. 2016-800 of 16 June 20…
…titutional Council has found that a law promulgated after the entry into force of the loi organique n° 2007-223 du 21 février 2007 précitée est intervenue dans les matières ressortissant à la compéten…
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